Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis

April 27, 2010 updated by: Belfast Health and Social Care Trust

A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.

The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in patients with mild to severe stable bronchiectasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast HSCT
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non CF Bronchiectasis
  • 18-80 years
  • FEV1 less than 90%
  • Chronic sputum production
  • Clinical stable

Exclusion Criteria:

  • Intolerance to HTS
  • Use of HTSaline or antibiotics 14 days prior to study
  • Clinically unstable
  • Smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour sputum volume
Time Frame: 13 weeks
24 hour volume sputum
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function Testing
Time Frame: 13 weeks
Spirometry (FEV1 and FVC) will assess the side effects using HTS.
13 weeks
Rheology
Time Frame: 13 weeks
Rheology is the measurement of the viscosity and elasticity of sputum (viscoelasticity) and also the thread forming ability of mucus (spinnibility). Rheology will assess the extent to which HTS effect the viscosity of secretions and rehydrates secretions by drawing water into the mucus via osmosis.
13 weeks
Adherence
Time Frame: 13 weeks
All used and unused vials of the study drug shall be counted. The researcher will review the returned vials (used and unused) along with the patient diary cards, which record information regarding airway clearance and administration of study drug.
13 weeks
Patient Reported Outcomes RSSQ
Time Frame: 13 weeks
RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.
13 weeks
Patient Reported Outcome: Leicester Cough Questionnaire:
Time Frame: 13 weeks

Leicester Cough Questionnaire: a valid and reliable health status measure for adults with chronic cough

Quality of Life Questionnaire Bronchiectasis (QOL-B), a tool used to evaluate quality of life in patients with bronchiectasis.
13 weeks
Bronchiectasis Qol Questionnaire
Time Frame: 13 weeks
Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09023JB-OPMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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